Certifications

We are certified to ISO 9001:2015 and ISO 15378:2017 standards, and operate in full compliance with current GMP requirements.

ISO 9001:2015

QUALITY MANAGEMENT SYSTEM.

ISO15378:2017

DEVELOPMENT AND MANUFACTURE OF PLASTIC PRIMARY PACKAGING FOR MEDICAL AND PHARMACEUTICAL PRODUCTS.

Our certification for the production of Class I Medical Devices according to Directive 93/42/EEC, Annex V, is currently on hold. But we have kept all procedures in place so we can readily undergo the re-certification audit and resume full compliance to manufacture Class I Medical Devices with CE-mark and with measuring function.